Table 2.
Outcome | Mifepristone-Pretreatment Group (N = 148) | Misoprostol-Alone Group (N = 149) | Relative Risk (95% CI)* |
---|---|---|---|
number (percent) | |||
Gestational sac expulsion by the first follow-up visit: treatment success† | 124 (83.8) | 100 (67.1) | 1.25 (1.09–1.43)‡ |
| |||
Gestational sac expulsion by the second follow-up visit at day 8 | 132 (89.2) | 111 (74.5) | 1.20 (1.07–1.33) |
| |||
With 1 dose of misoprostol | 130 (87.8) | 106 (71.1) | |
| |||
With 2 doses of misoprostol | 2 (1.4) | 5 (3.4) | |
| |||
Gestational sac expulsion by the 30-day telephone call | 135 (91.2) | 113 (75.8) | 1.20 (1.08–1.33) |
| |||
With 1 dose of misoprostol | 130 (87.8) | 106 (71.1) | |
| |||
With 2 doses of misoprostol | 5 (3.4) | 7 (4.7) | |
| |||
Uterine aspiration§ | 13 (8.8) | 35 (23.5) | 0.37 (0.21–0.68) |
Relative risks were adjusted for trial site with use of the Mantel–Haenszel method.
Treatment success was defined as gestational sac expulsion with one misoprostol dose by the first follow-up visit and no additional intervention within 30 days after treatment.
The rate of treatment success by the first follow-up visit was significantly higher in the mifepristone-pretreatment group than in misoprostol-alone group (P<0.001).
Indications for uterine aspiration included participant request and clinical recommendation.